[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603662":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":19,"responsibleParty":20,"collaborators":19,"id":22,"slug":23,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":27,"acronym":28,"eligibilityCriteria":29,"healthyVolunteers":30,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":19,"studyType":37,"phases":38,"briefSummary":40,"conditions":41,"keywords":43,"overallStatus":45,"whyStopped":19,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":19},{"fullName":5,"class":6},"Nuwacell Biotechnologies Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NCR100 injection","EXPERIMENTAL","Subjects will receive a single injection of NCR100",[13],"Biological: NCR100",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","NCR100",[9],null,{"type":21,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100603662","phase-1-a-study-of-89zr-oxine-ncr100-injection-for-the-cellular-distribution-100603662",false,"NCT07139431","A Study of [89Zr]-Oxine-NCR100 Injection for the Cellular Distribution","A Study to Evaluate the Cellular Distribution of [89Zr]-Oxine-NCR100 Injection in the Treatment of Subjects With Knee Osteoarthritis","Distribution","Inclusion Criteria:\n\n* Subjects who understand and voluntarily sign the Informed Consent Form（ICF） before enrolment; Age: 40-70 years old, both genders; Men without reproductive intentions; Diagnosis of knee osteoarthritis based on American College of Rheumatology criteria.\n\nSubjects with KOA who have persistent pain for more than six months, Kellgren-Lawrence grade: II-III; McMaster University's Osteoarthritis Index (WOMAC) of the study-side knee joint: 60-180.\n\nExclusion Criteria:\n\n* Subjects previously diagnosed with secondary knee osteoarthritis, or those diagnosed with hip\u002Fankle joint disease requiring medical intervention; Subjects previously diagnosed with secondary knee osteoarthritis, or those diagnosed with hip\u002Fankle joint disease requiring medical intervention; Have received stem cell therapy; Experienced knee surgery, or plan to undergo knee surgery; Have used traditional Chinese medicine to treat KOA within 4 weeks; Have used intra-articular injection of drugs to treat KOA within 12 weeks; Received glucosamine, chondroitin sulfate, or diacetate therapy before investigational drug intervention within 12 weeks; Subjects with the acute phase of knee osteoarthritis; severe deformity of the knee; BMI≥30kg\u002Fm\\^2; Severe systemic infection or local knee joint infection; Have received systemic glucocorticoid therapy before intervention or need to take systemic glucocorticoid therapy during the treatment; Have serious heart disease； Subjects with peripheral or central nervous system disorders that may interfere with assessments; Have contraindications to Magnetic Resonance Imaging(MRI); Subjects with alcohol\u002Fdrug addiction\u002Fabuse or mental disorders; Have participated in other clinical trials within 12 weeks before the screening; Subjects with infection with hepatitis B virus(HBV), hepatitis C virus(HCV), HIV, and Treponema pallidum confirmed by laboratory tests; Subjects with a history of allergic reaction to any component of the trial drug or to acetaminophen; Subjects who are not suitable for PET\u002FCT examination.",true,"MALE","40 Years","70 Years",{"count":35,"type":36},6,"ESTIMATED","INTERVENTIONAL",[39],"PHASE1","This clinical study is to evaluate the biodistribution of \\[89Zr\\]-Oxine-NCR100 injection in subjects with knee osteoarthritis after local injection and the kinetic behavior characteristics of zirconium-labeled cells at the injection site and various organs or tissues. It is a single-dose, open-label study in adult KOA subjects.",[42],"KOA",[44],"MSC, KOA","NOT_YET_RECRUITING","2025-08-17",{"date":48,"type":49},"2025-08-24","ACTUAL",{"date":51,"type":36},"2025-08-29",{"date":53,"type":36},"2028-04-21",{"name":5,"class":6}]